Refractory hepatic encephalopathy (RHE) after transjugular intrahepatic portosystemic shunt (TIPS) is a serious complication that can markedly impair quality of life and worsen prognosis. Standard medical management-including lactulose, rifaximin, nutritional support, and correction of precipitating factors-is routinely used; however, some patients continue to experience recurrent hepatic encephalopathy despite optimized therapy.
TIPS shunt reduction is an established interventional option for RHE, but current techniques may provide limited ability to precisely control the degree of flow reduction while maintaining procedural safety. The investigators developed a coil-assisted, small-diameter covered-stent technique that deploys coils as an anchor within the existing TIPS tract, followed by placement of a 6-mm balloon-dilated covered stent to achieve controlled reduction in shunt flow.
This single-center ambispective cohort study will evaluate the efficacy and safety of this technique in patients with RHE after TIPS by including both retrospective and prospective cohorts. Outcomes will include hepatic encephalopathy severity and recurrence, stent patency, portal hypertension-related complications, changes in portal pressure gradient, liver function parameters, transplant-free survival, and procedure-related adverse events.
Prior transjugular intrahepatic portosystemic shunt (TIPS) placement;
Confirmation of patent TIPS stent via imaging and/or hemodynamic evaluation;
Recurrent episodes of grade II or higher hepatic encephalopathy (by West-Haven criteria) occurring more than twice within a 4-week period, despite standard medical therapy including lactulose, rifaximin, nutritional support, and correction of precipitating factors;
Treatment with coil-assisted small-diameter stent shunt reduction;
Presence of severe extrahepatic organ failure (e.g., cardiac, pulmonary, or renal failure);
Significant missing data that precludes evaluation in the retrospective cohort.
Single group
Coil-assisted Small-diameter Stent Shunt reduction
Procedure/SurgeryCoil-assisted Small-diameter Stent Shunt reduction: 1. Puncture of the right internal jugular vein, followed by catheter introduction into the existing TIPS stent. 2. Performance of portal venography and measurement of baseline portal pressure gradient. 3. Deployment of a 10-mm coil within the existing TIPS stent as an anchoring point. 4. Delivery and deployment of a 6-mm covered stent within the existing TIPS stent to create a narrowed flow channel. 5. Balloon dilation at both ends of the stent to ensure adequate apposition with the original TIPS stent. 6. Post-procedural portal venography to assess stent patency, portal pressure gradient, and hepatic perfusion.
Incidence of overt hepatic encephalopathy
Hepatic encephalopathy is classified according to the 2022 European Association for the Study of the Liver (EASL) Clinical Practice Guidelines using the West-Haven criteria. Overt hepatic encephalopathy is defined as grade II or higher.
Stent occlusion
Stent occlusion will be evaluated by imaging examinations, including Doppler ultrasound, contrast-enhanced CT, or angiography. Stent occlusion is defined as complete loss of patency of the shunt.
variceal rebleeding
Clinically significant rebleeding is defined in accordance with the Baveno V consensus criteria and is identified by recurrence of melena or hematemesis accompanied by any of the following: a) requirement for hospitalization; b) need for blood transfusion; c) hemoglobin decrease of ≥3 g/dL; or d) death within 6 weeks.
New or worsening ascites
Defined as an increase of at least one grade in ascites severity on ultrasound (grading criteria: Grade 0 = none, Grade 1 = mild, Grade 2 = moderate, Grade 3 = large), or persistent ascites requiring paracentesis.Grade 1: Ascites detected only by ultrasound, without abdominal distension. Shifting dullness is negative. Ultrasound shows ascites in abdominal spaces with a depth of \<3 cm.Grade 2 : Moderate abdominal distension with symmetrical enlargement. Shifting dullness may be negative or positive. Ultrasound shows ascites surrounding the intestines but not extending beyond the mid-abdomen, with a depth of 3-10 cm.Grade 3: Marked abdominal distension, positive shifting dullness, and possible abdominal bulging or umbilical hernia. Ultrasound shows ascites occupying the entire abdominal cavity, with a depth of \>10 cm.
Portosystemic pressure gradient (PSPG) before and immediately after the procedure
Portosystemic pressure gradient (PSPG) will be measured before and immediately after the flow restriction procedure to evaluate hemodynamic changes.
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